Z-0479-2026Class II

BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000

Name: Z-0479-2026 BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000
Creator: Miach Orthopaedics
Published: 2023-02-02
License: https://open.fda.gov/license/

Miach Orthopaedics / initiated 2023-02-02 / Open, Classified

FDA source

Miach Orthopaedics began a recall of BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000 on 2023-02-02. FDA classified it as Class II and gives the reason as "The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0479-2026
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-02
Posted: 2025-11-07
Recalling firm: Miach Orthopaedics
Product: BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Product code: QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Reason for recall: The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
FDA root cause: Under Investigation by firm
Action: On January 30, 2023 RE: BEAR Implant Hydration memo emails were sent to sales staff. If you observe an implant that hydrates too quickly (e.g., less than 30 seconds) and appears that it may not remain intact upon insertion into the knee, do not attempt to implant the device. We would recommend you always have a backup device available to address such circumstances. We plan to revise the Tips and Pearls document, ML-1027, to provide further instructions/details on how to properly hydrate the BEAR device. In the meantime, one way to avoid shortened hydration time is to consider hydrating the dense side of the implant first and continue toward the porous side . To date, all reports of this observation have involved Lot # 7008409. As a precaution and to ensure customer satisfaction, we are asking that you return all devices from this lot that are currently in your trunk stock (in your possession). Chris Brown will work with you to coordinate returns as well as replacing these trunk stock devices. Please contact me ([email protected]) or Arjun ([email protected]) if you have questions.
Quantity in commerce: 167 units
Distribution: US Nationwide distribution.
Product codes and lots: Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0479-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0479-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

Product code QNI

K243578Class IIBEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc. / cleared 2025-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)